Full Time Manager, Quality Assurance - Regulatory Affairs Jobs, in DKSH Selangor - Maukerja

Job summary

Responsible for ensuring that all medical device products and related operations comply with applicable regulatory requirements, quality standards, and company policies. This role will oversee the development, implementation, and continuous improvement of the Quality Management System (QMS), and manage regulatory submissions, approvals, and licenses for medical device products. The position requires close collaboration with internal stakeholders, principals, and regulatory authorities to maintain product compliance and enable business growth.

General responsibilities

• Develop, implement, and maintain quality management systems (QMS) in alignment with ISO 13485, GDPMD, and other relevant standards and regulatory requirements.

• Plan and coordinate internal and external audits, inspections, and assessments, ensuring timely closure of any findings.

• Review and approve quality-related documents, SOPs, and technical files.

• Monitor and ensure compliance with product registration, licensing, and regulatory submissions to the Medical Device Authority (MDA) and other relevant bodies.

• Provide regulatory guidance and support during product launches, product changes, and business expansions.

• Lead investigations of product quality issues, non-conformances, and customer complaints, implementing effective CAPAs.

• Maintain up-to-date knowledge of regulatory changes and assess their impact on business operations.

• Serve as the point of contact for regulatory agencies and principals on quality and regulatory matters.

• Prepare and present reports on quality and regulatory performance to management.

• Provide subject matter expertise in QA & RA to guide and support cross-functional teams.

• Influence and collaborate with internal stakeholders to drive compliance culture and operational excellence.

• Role model DKSH People DNA behaviors in daily work and interactions.

• Take ownership of own development and actively contribute to building organizational capability in QA & RA.

Functional skills and knowledge

• Minimum 6–8 years of progressive experience in Quality Assurance and Regulatory Affairs within the medical device industry.

• Proven experience managing QMS, audits, and regulatory submissions in compliance with Malaysian MDA requirements.

• Exposure to working with multinational principals and regulatory agencies is highly preferred.

• Prior experience in an individual contributor role with cross-functional project responsibilities.

• Strong understanding of ISO 13485, GDPMD, MDR, and other relevant international and local regulatory frameworks.

• Hands-on experience in QMS implementation, audits, and regulatory submissions.

• Knowledge of product registration, licensing, and post-market surveillance requirements for medical devices in Malaysia.

• Analytical and problem-solving skills with a keen attention to detail.

• Effective communication and stakeholder management skills to work cross-functionally with principals, authorities, and internal teams.

• Ability to manage multiple priorities and deliver under tight timelines.

Education

• Bachelor’s degree in Pharmacy, Biomedical Science, Biotechnology, Life Sciences, Engineering, or related field.

• Postgraduate qualifications or certifications in Regulatory Affairs or Quality Management will be an added advantage.